We have an ejection problem!

With the new year, we're eager to move in to the clinic and start our dosing. But there are many steps required, which is part of why developing drugs is so hard.

I've been doing this since 1989. I knew it was hard. But I did not know how hard. And now, as we are about to complete the manufacturing of RB-190 and matching placebo tablets, we have an ejection problem. That's right, we have a manufacturing hiccup.

This animation shows two types of machines used to make tablets via compression, which means taking an exact amount of the medicine and applying several tons of pressure to form a tablet. In the first half of the video, the problem is step 4 and in the second half it is step 5 - in each case where the compressed tablet is ejected from the cylinder within which it was compressed (the die). In our case, the pills are getting stuck, so the machine needs to be stopped and restarted. That is not efficient enough to make the thousands of tablets we need for the clinical trial. So we need to add a lubricant to reduce friction and allow the pills to be ejected.

While this seems simple, and is in fact fairly simple, there are important implications. We can use the pills we've made even when they intermittently got stuck - as long as they pass the necessary tests for purity, stability etc. But we decided to make the tablets using only half of our drug supply at a time, just in case something major went wrong. Fortunately this is not major, but when we make the tablets with lubricant added, we now need to test that second batch separately. So there will be some added time (likely a few weeks) and meaningful added expense to run those purity, stability etc. testing on each batch.

We'll solve our ejection problem as we've done whenever a problem arose on the path so far. And we'll solve those problems that we will face in the coming months as we move towards launch of the clinical trial this year (I proclaim optimistically).

Funding Update

As planned, we resubmitted our grant application to the Michael J. Fox Foundation in December. And in the week that followed, they asked some clarifying questions - administrative in nature - that appeared to show a higher level of interest in our approach than displayed to date. So here we are, continuing to be optimistic that the Foundation will commit to supporting the development of RB -190. We'll know in March.